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The U.S. Food and Drug Administration (FDA) has licensed Pfizer’s coronavirus vaccine for emergency use, paving the way for millions of highly vulnerable Americans to contract it within days, the New York Times noted.
FDA had already said was working “quickly” to authorize the emergency use of the Pfizer / BioNTech covid-19 vaccine, after an advisory committee thoroughly analyzed the research results submitted by the companies and gave them the go-ahead.
(You may be interested in: How is Colombia going in the race to access vaccines against covid-19?)
“Following the positive outcome of yesterday’s advisory committee meeting regarding the Pfizer-BioNTech vaccine, the FDA informed the sponsor that it will work expeditiously to finalize and issue an emergency use authorization.
The agency also notified the U.S. Centers for Disease Control and Prevention (CDC) and Operation Warp Speed so that they can execute their plans for the timely distribution of the vaccine “, published the entity on its page.
Pfizer’s BNT162b2 vaccine, based on data analyzed, is 95 percent effective after two 30-microgram doses are given, 21 days apart.
The FDA also assured through its Twitter account that “the available data provides clear evidence that the vaccine can be effective in preventing COVID-19” and also stated that “the data also supports that the known and potential benefits exceed those potential risks, supporting the use of the vaccine in millions of people 16 years of age and older, including healthy people “
The data also supports that the known and potential benefits outweigh the known and potential risks that support the use of the vaccine in millions of people 16 years of age and older, including healthy people.
– US FDA (@US_FDA) December 12, 2020
The data also supports that the known and potential benefits outweigh the known and potential risks that support the use of the vaccine in millions of people 16 years of age and older, including healthy people.
– US FDA (@US_FDA) December 12, 2020
(Also read: AstraZeneca and Russia will test efficacy by combining their vaccines)
And while the data presented by its developer pharmaceuticals indicates that a single dose achieves close to 52 percent protection, the FDA does not provide an absolute conclusion on this issue, and the trial did not have systematic comparisons on this measure.
Regarding the safety of this vaccine, it was rated as favorable, after showing common reactions such as local events at the site of application, fatigue, headache, chills, fever and pain in the thousands of volunteers in phase III trials. muscular. Serious forms of adverse events were found in 4.6 percent of the participants, more frequently after the second dose and in older adults.
It should be said that this Wednesday, the United Kingdom, where this same vaccine began to be applied on Tuesday after the approval of last week, recommended not to administer it to people who have had a serious allergic history in the past, after two health workers showed anaphylactic-type reactions.
(Further: Pfizer’s vaccine is effective and safe: ‘New England Journal of Medicine’)
As we do not have enough data to draw conclusions about the safety of the vaccine in some populations such as children under 16 years of age, pregnant and lactating women, the expert committee does not recommend its application in them.
FDA experts also learned that six participants died in the trials. Faced with them, it was concluded that they were deaths from events that occur in the general population in the age groups where they occurred at a similar rate.
Implications
If it occurs, the FDA’s decision can be considered historic because this health agency serves as a reference for many countries. In fact, in some nations it is enough for a product to be approved by that body to allow its use. Hence, the conclusions and recommendations given could be the same as those followed in much of the world.
(Read also: Save humanity with a vaccine and earn billions from it)
As it has become known, this vaccine would be distributed in the coming days throughout the United States to be applied in the populations most vulnerable to covid-19, as are older people, with risky comorbidities and in health workers from the first line of care.
All this in an emergency context in which the United States presents records of daily cases and deaths like never before seen in the pandemic. Daily it is reporting more than 200,000 infections and about 3,000 deaths.
HEALTH UNIT
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